We wrote about Minerva Neursciences (NERV) when they were just completing some important corporate goals in anticipation of upcoming clinical trials. The lead drug is MIN-101 for negative symptoms of Schizophrenia, which is scheduled to start a 500 patient study soon. Patients will be recruited throughout Europe, with 30% of participants coming from the US. Currently there is not an FDA approved drug for negative symptoms of Schizophrenia, so this fits into our category of an unmet medical need. The phase 2 clinical trial with MIN-101 proved to be effective. The results of that clinical trial are below.
PANSS Negative Symptom Score at 12 Weeks
- 32mg p = 0.021 effect size .45
- 64mg p = 0.003 effect size . 58
The 500 patient phase 3 study is to determine if MIN-101 is effective again, for the negative symptoms of Schizophrenia. The patent for MIN-101 extends out to 2035. Thank you for reading.
This is the second phase 3 clinical trial for patients with schizophrenia and Intra-Cellular drug ITI-007. This trial had Risperidone as an active comparator and a placebo arm, the clinical trial is here NCT02469155. I am including our write up on the first phase 3 clinical trial (Study '301) here ITI-007 Phase 3 Results, for the specific reason of attempting to uncover how ITI-007 has performed on the PANSS Negative Symptoms subscale. The first phase 3 clinical trial did not show statistically significant improvement in the PANSS Negative Symptoms subscale from the company PR in September of 2015. Below are the results for the ITI-302 phase 3 study.
- 60 mg -14.6
- 20 mg -15.0
- Risperidone 4mg -20.1
- Placebo -15.1
Today (Study '302) the company released phase 3 clinical trial top line results, that did not mention any significance to the Negative Symptoms in the Intra-Cellular press release. Intra-Cellular's ITI-007 results today should create some skepticism regarding the drug as a viable CNS candidate for Schizophrenia as Risperidone outperformed ITI-007. The PANSS Negative Symptom subscale had zero mention from today's top-line press release. Based on the two phase 3 clinical trials, ITI-007 does not have a strong effect on the PANSS Negative Symptoms subscale. AVP-786 is currently in clinical trials being tested for negative symptoms associated with schizophrenia. Thank you for reading.
